Cartridge from which bone cement is discharged, the cartridge having a removable couple nozzle

ABSTRACT

A cartridge in which bone cement is mixed and from which the cement is discharged. A blade with plural vanes is disposed in the cartridge for mixing the cement. A piston located in one end of the cartridge is actuated to push the mixed cement out of the cartridge. The blade has plural vanes, one for scraping cement off the side of the cartridge, one for scraping cement off the piston and one for scraping cement off the end of the cartridge opposite the end in which the piston is normally located. The blade is collapsible so that when the piston is actuated the blade compresses to allow the cement in the cartridge to be pushed out.

RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.12/704,618 filed 12 Feb. 2010 now U.S. Pat. No. ______. application Ser.No. 12/704,618 is a divisional of U.S. patent application Ser. No.12/138,620, filed 13 Jun. 2008, now U.S. Pat. No. 7,677,418. applicationSer. No. 12/138,620 is a divisional of application Ser. No. 11,837,649filed 13 Aug. 2007, now U.S. Pat. No. 7,393,342. application Ser. No.11/837,649 is a divisional of application Ser. No. 10,843,813, filed 12May 2004, now abandoned. application Ser. No. 10/843,813 claims thebenefit of U.S. provisional patent application Ser. No. 60/469,651,filed 12 May 2003 and U.S. provisional patent application Ser. No.60/520,877, filed 18 Nov. 2003. The advantages and disclosures of theabove listed priority applications are herein incorporated by reference.

FIELD OF THE INVENTION

This invention generally relates to a bone cement mixing and deliverysystem. More specifically, the present invention relates to a mixingcartridge for receiving liquid and powder components of bone cement tobe mixed, a mixing device for mixing the components, and a delivery gunfor discharging the bone cement from the mixing cartridge into ananatomical site of a patient

BACKGROUND OF THE INVENTION

Bone cement mixing and delivery systems are well known for mixing liquidand powder components of bone cement and delivering the prepared bonecement to an anatomical site during various surgical procedures. Bonecement is particularly useful in orthopedic procedures in which aprosthetic device is fixed to a bone or joint structure to improve thestrength, rigidity, and movement of the structure. In a total hiparthroplasty (THA) procedure, in which a hip joint is replaced with aprosthetic device, bone cement is used to fix the prosthetic device inplace in a medullary canal of a femur.

Typically, the bone cement is prepared in a mixing cartridge. The mixingcartridge includes a cylinder having proximal and distal ends with amixing chamber defined between the ends. The mixing cartridge furtherincludes a cap covering the proximal end of the cylinder and a pistondisposed in the distal end of the cylinder such that the mixing chamberis further defined between the cap and the piston. The piston may bereleasably secured in a locked position in the cylinder by a cotter pin.The cap supports a mixing device, i.e., a mixing shaft and blade, formixing the liquid and powder components of the bone cement in the mixingchamber.

Once the bone cement is mixed, the mixing cartridge is prepared forinserting into a delivery gun to discharge the bone cement. This mayinclude disengaging the mixing shaft and coupling a nozzle to the cap toprovide a discharge point for the bone cement. At the same time, thepiston is released from the locked position in the distal end of thecylinder by pulling the cotter pin. This allows the piston to be drivenby the delivery gun through the mixing chamber to discharge the bonecement from the nozzle. An alternative solution for securing andreleasing the piston is shown in U.S. Pat. No. 5,328,262 to Lidgren etal.

In Lidgren et al., the piston is releasably secured in the lockedposition in the distal end of the cylinder by a gripping portion in theform of a flange, which extends along only a portion of an innerperiphery of the cylinder. The piston in Lidgren et al. has acorresponding gripping portion in the form of an outwardly directed lipthat protrudes behind the flange. The lip defines a groove with an outersurface of the piston to receive the flange. To release the piston fromthe locked position, the flange is rotated through the groove until theflange has been rotated past the lip. Lidgren et al. discloses a basethat is used to secure the piston from rotation while a user rotates thecylinder relative to the piston to release the piston from the lockedposition. This method of releasing the piston from the locked position,much like pulling the cotter pin, requires additional manipulation by auser.

Once the piston is released from the locked position, the mixingcartridge is inserted into the delivery gun. A typical delivery gunincludes a ram disk that engages the piston and drives the pistonthrough the mixing chamber to discharge the bone cement from the nozzle.The delivery gun includes a cradle for supporting the mixing cartridgeand a casing for supporting a drive rod that engages the ram disk andadvances the ram disk to drive the piston. The drive rod includes aplurality of teeth and a pawl member engages the teeth to advance thedrive rod. A trigger supports the pawl member and the casing rotatablysupports the trigger. Actuation of the trigger relative to the casingurges the pawl member against the teeth to advance the drive rod.

An example of such a delivery gun is illustrated in U.S. Pat. No.5,431,654 to Nic. In the '654 patent to Nic, two pawl members are usedto independently advance the drive rod and the ram disk. The pawlmembers provide high speed/low force and low speed/high forceadvancement of the drive rod. A switch is used to select between thespeeds. When high speed is selected, both pawl members engage the driverod, while only the high-speed pawl member actually advances the driverod. When low 1’ speed is selected, the high-speed pawl member isisolated from the teeth such that only the low speed pawl member engagesthe teeth to advance the drive rod. However, in Nic, the triggerdirectly supports each of the pawl members which results in a lowmechanical advantage to advance the drive rod and ram disk.

BRIEF SUMMARY OF THE INVENTION

A mixing cartridge for receiving liquid and powder components of bonecement to be mixed for medical use. The mixing cartridge comprises acylinder having proximal and distal ends with a mixing chamber definedtherebetween. The cylinder includes a cylinder wall extending betweenthe ends about a longitudinal axis of the cylinder. A piston is disposedin the cylinder at the distal end such that the mixing chamber isfurther defined between the proximal end and the piston. A lockingmember is coupled to the piston to lock the piston in the distal end.The locking member includes a male portion engaging a female portion inthe cylinder wall to place the piston in a locked position at the distalend of the cylinder. The locking member includes a resilient portion forbiasing the male portion into mating engagement with the female portion.The piston remains in the locked position at the distal end of thecylinder while mixing the liquid and powder components.

One advantage of the mixing cartridge is the conveniently positionedlocking member used to lock the piston in the distal end. By using theresilient portion to bias the male portion into mating engagement withthe female portion, a user can easily release the piston from the lockedposition by either manually or mechanically acting against the bias ofthe resilient portion to disengage the male and female portions.

A delivery gun is also provided for discharging the bone cement from thecartridge once the bone cement is prepared. The delivery gun comprises acasing for supporting the cartridge. A drive mechanism is supported bythe casing and advanceable relative to the casing to force the bonecement from the cartridge. The casing pivotally supports a triggeroperatively connected to the drive mechanism to advance the drivemechanism upon actuation of the trigger to force the bone cement fromthe cartridge. A linkage system works in conjunction with the trigger toadvance the drive mechanism. The linkage system comprises a first linkpivotally connected to the casing and a second link interconnecting thefirst link and the trigger such that actuating the trigger moves thesecond link and the first link to advance the drive mechanism.

An advantage of the delivery gun is the use of the linkage system toincrease the mechanical advantage needed to successfully advance thedrive mechanism and force the bone cement from the cartridge whileminimizing fatigue to a user of the delivery gun.

In one aspect of the delivery gun, the drive mechanism includes a driverod and gripper plates to advance the drive rod. The gripper platesfrictionally engage the drive rod to advance the drive rod when thetrigger is actuated. In one embodiment, the gripper plates includemating pegs and notches to align adjacent gripper plates. In anotherembodiment, the gripper plates are coated to increase lubricity andcorrosion resistance thereof.

In another aspect of the delivery gun, the drive mechanism includes adrive rod and first and second pawl members to advance the drive rod. Inone embodiment, the second pawl member is movable into engagement withteeth on the drive rod for high-speed advancement of the drive rod andout from engagement with the teeth for low-speed advancement. Duringlow-speed advancement, only the first pawl member engages the teeth toadvance the drive rod. During high-speed advancement, both pawl membersengage the teeth, but only the second pawl member works to advance thedrive rod.

A bone cement mixing and delivery system is also provided. The mixingand delivery system includes the cartridge and the delivery gun. In thisaspect of the invention, the locking member includes a release button torelease the piston from the locked position. At the same time, thedelivery gun includes a release mechanism integrated into the drivemechanism to engage the release button. When the cartridge is placedinto the cradle of the delivery gun, the drive mechanism is advanced andthe release mechanism engages the release button to release the pistonfrom the locked position. This configuration reduces the number of stepstypically associated with releasing the piston. By incorporating therelease mechanism into the drive mechanism, when the drive mechanism isadvanced, the piston is automatically released.

A bone cement loading system for receiving the liquid and powdercomponents of the bone cement is also provided. The loading systemincludes the cylinder with the piston locked in the distal end. A basedefining a cavity is provided for receiving and securing the distal endof the cylinder. A funnel is provided for coupling to the proximal endof the cylinder to channel the powder component of the bone cement intothe mixing chamber. The funnel has a proximal end with an oblongoval-shaped periphery to facilitate loading of the powder component ofthe bone cement into the mixing chamber and a distal end with a circularperiphery for snugly fitting into the proximal end of the cylinder. Oneparticular advantage to this loading system is the use of the oblongoval-shaped funnel. The shape of the funnel reduces any mess typicallyassociated with filling the mixing chamber with powder.

A bone cement mixing system comprising the mixing cartridge and a mixingshaft and blade is also provided. The blade is coupled to the mixingshaft and disposed in the mixing chamber for rotating with the mixingshaft about the longitudinal axis to mix the liquid and powdercomponents of the bone cement. The blade includes a center hub coupledto the mixing shaft and an outer ring extending from the center hub. Theouter ring forms an acute angle with the longitudinal axis of betweentwenty and seventy degrees to ensure adequate mixing of the bone cementin the mixing chamber.

A method of mixing the liquid and powder components of the bone cementin the mixing chamber is also provided. The method includes using arotary power tool connected to a portion of the mixing shaft extendingoutside of the mixing chamber to mix the liquid and powder components ofthe bone cement. The blade is disposed in the mixing chamber while beingoperatively connected to the portion of the mixing shaft extendingoutside of the mixing chamber. In the method, the rotary power tool isfirst connected to the portion of the mixing shaft extending outside ofthe mixing chamber. Then the rotary power tool is actuated to rotate theblade and mix the liquid and powder components of the bone cement. Atthe same time, the rotary power tool is axially displaced relative tothe mixing cartridge to completely mix the liquid and powder componentsof the bone cement. Once mixing is complete, the operative connectionbetween the blade and the portion of the mixing shaft extending outsideof the mixing chamber is removed.

BRIEF DESCRIPTION OF THE DRAWINGS

Advantages of the present invention will be readily appreciated as thesame becomes better understood by reference to the following detaileddescription when considered in connection with the accompanying drawingswherein:

FIG. 1 is an exploded perspective view of a mixing cartridge of thepresent invention in combination with a mixing shaft and blade;

FIG. 2 is an assembled perspective view of the mixing cartridge with themixing shaft and blade supported therein;

FIG. 3 is an exploded perspective view of a cap of the mixing cartridge;

FIG. 4 is a cross-sectional view of the cap of FIG. 3 and a partialcross-sectional view of a cylinder of the mixing cartridge to illustratefitting of the cap to the cylinder;

FIG. 5 is an exploded perspective view of the cap and the mixing shaftand blade;

FIG. 6 is an assembled perspective view of the cap with the mixing shaftand blade supported therein;

FIG. 7 is a perspective view of the blade;

FIG. 7A is a side elevational view of the blade of FIG. 7;

FIGS. 8-8A and 9 are perspective views of alternative blades;

FIG. 10 is a an exploded perspective view of the mixing shaft and alatch rod;

FIG. 11 is an elevational end view of the mixing shaft and latch rod ofFIG. 10;

FIG. 12 is a cross-sectional view of the mixing shaft and latch rod ofFIGS. 10 and 11;

FIG. 13 is an exploded perspective view of a release latch coupling themixing shaft and latch rod;

FIGS. 14A-14C illustrate the release of the blade from the mixing shaft;

FIG. 15 is an exploded perspective view of a piston of the mixingcartridge;

FIG. 16 is a cross-sectional view of the piston of FIG. 15;

FIG. 17 is a perspective view of an alternative piston of the mixingcartridge;

FIG. 18 is a top view of the alternative piston of FIG. 17;

FIG. 19 is an exploded perspective view of the cap and a nozzle;

FIG. 20 is an assembled perspective view of the cap and nozzle;

FIG. 21 is a blown-up view of a locking mechanism of the cap and nozzle;

FIGS. 22-23 are perspective views of the nozzle;

FIG. 24 is a perspective view of a delivery gun of the present inventionillustrating a linkage system of the delivery gun;

FIGS. 24A-24B illustrate alternative linkage systems of the presentinvention;

FIG. 25 is an elevational view illustrating release of a locking membersecuring the piston;

FIG. 26 is a partial perspective view of an alternative linkage systemand drive mechanism of the delivery gun;

FIG. 27 is a partial perspective view of the alternative linkage systemand drive mechanism of FIG. 26 employing a striker to prevent freeze-upof the drive mechanism;

FIG. 28 is an elevational view of a second alternative embodiment of thelinkage system and drive mechanism of the delivery gun in a low-speedposition;

FIG. 29 is a perspective view of the second alternative embodiment ofthe linkage system and drive mechanism in the low-speed position;

FIG. 30 is an elevational view of the second alternative embodiment ofthe linkage system and drive mechanism in a high-speed position;

FIG. 31 is a perspective view of the second alternative embodiment ofthe linkage system and drive mechanism in the high-speed position;

FIG. 32 is an exploded view of a cylinder of the mixing cartridge and abase and funnel used to fill the cylinder with components of bonecement; and

FIGS. 33-42 illustrate various steps associated with the presentinvention.

DETAILED DESCRIPTION OF THE INVENTION

Referring to the Figures, wherein like numerals indicate like orcorresponding parts throughout the several views, a bone cement mixingand delivery system is generally shown. The bone cement mixing anddelivery system comprises a mixing cartridge 100 for receiving liquidmonomer and powdered copolymer components of bone cement to be mixed, amixing device (mixing shaft 150 and blade 152) for mixing thecomponents, and a delivery device, e.g., a delivery gun 500, fordischarging the bone cement from the mixing cartridge 100 into ananatomical site (not shown). An exemplary use for the bone cement is tosecure a prosthetic device used to replace a joint structure such as ina total hip arthroplasty (THA) procedure.

Referring to FIGS. 1 and 2, the bone cement mixing system comprises themixing cartridge 100 in combination with the mixing shaft 150 and blade152 used to mix the components of the bone cement in the mixingcartridge 100. The mixing cartridge 100 includes a cylinder 102 havingproximal 104 and distal 106 ends. A mixing chamber 108 is definedbetween the ends 104, 106. The cylinder 102 includes a cylinder wall 110extending between the ends 104, 106, about a longitudinal axis L. A cap112 is coupled to the cylinder 102 at the proximal end 104 and a piston114 is disposed in the cylinder 102 at the distal end 106 such that themixing chamber 108 is further defined between the cap 112 and the piston114. The components of the bone cement are placed in the mixing chamber108 and mixed by the mixing shaft 150 and blade 152, as will bedescribed further below.

In the preferred embodiment, the cylinder 102 has locking strips 116disposed on the cylinder wall 110 at the proximal end 104 to insert intolocking slots 118 on the cap 112. Each of the locking strips 116 includea straight portion lying perpendicular relative to the longitudinal axisL and an angled portion lying at an angle relative to the straightportion. As should be appreciated, the locking strips 116 and lockingslots 118 could be reversed, i.e., the locking strips 116 positioned onthe cap 112 and the locking slots 118 defined in the cylinder wall 110.The locking strips 116 and locking slots 118 are configured to providequick locking of the cap 112 onto the cylinder 102 with a one-quarterturn of the cap 112. Those of ordinary skill in the art will appreciatethat numerous methods are available for connecting the cap 112 to thecylinder 102, such as mating threads, snap-fit connections, etc. Agroove 120 is formed in the cylinder 102 at the proximal end 104 to seatan o-ring seal 122. The o-ring seal 122 assists in sealing the cap 112to the cylinder 102.

Referring to FIGS. 3-4, the cap 112 includes radially inwardlyprotruding ramps 124 that lead into the locking slots 118 to facilitatethe fit with the locking strips 116 on the cylinder wall 110. When firstplacing the cap 112 on the cylinder 102, the locking strips 116 arepositioned between the ramps 124. As the cap 112 is rotated, the ramps124 cam the locking strips 116 proximally to urge the proximal end 104of the cylinder 102 into a sealed relationship with the cap 112, asshown in FIG. 4 (only a portion of the cylinder wall 110 with twolocking strips 116 is shown in FIG. 4 for illustrative purposes). In thepreferred embodiment, there are four locking strips 116 and four lockingslots 118 to facilitate the sealed relationship between the cap 112 andthe cylinder 102.

Referring specifically to FIG. 4, an o-ring seal 126 and dynamic seal128 operate together within an orifice 130 in the cap 112 to movablysupport and seal to the mixing shaft 150. The mixing shaft 150 slidesthrough the orifice 130 and the dynamic seal 128 and is movablysupported therein. The dynamic seal 128 allows nearly frictionlessrotational, as well as axial movement of the mixing shaft 150 within themixing chamber 108 to mix the liquid and powder components of the bonecement, while maintaining a snug fit within the orifice 130. A filter132 and liner 134 are positioned on an interior of the cap 112 to allowa vacuum to be drawn in the mixing chamber 108 by way of a vacuum port136. The vacuum port 136 is isolated from the mixing chamber 108 by thefilter 132 and liner 134 to prevent fouling of a vacuum pump (notshown). Referring to FIGS. 5-6, a vacuum tube 138 is shown attached tothe vacuum port 136 to draw the vacuum in the mixing chamber 108 duringmixing.

Referring to FIG. 7, the preferred blade 152 used to mix the bone cementis shown. The blade 152 is integrally formed from plastic in one pieceand has an outer ring 154 connected to a center hub 156 by vanes 158.Ears 160 protrude radially inwardly from the center hub 156 tofacilitate a releasable connection to the mixing shaft 150. Thereleasable connection is described further below. Referring to FIG. 7A,the outer ring 154 forms an acute angle a with the longitudinal axis Lof the cylinder 102 (which is also a rotational mixing axis of the blade152). The acute angle a is important for efficient mixing of the bonecement. The acute angle a is preferably between twenty and seventydegrees, and more preferably sixty degrees. The blade 152 has aneffective height H that is greater than one quarter inch to ensureadequate mixing. Preferably, the effective height H of the blade 152 isapproximately one half inch.

Referring back to FIG. 7, two radially inwardly protruding fingers 157are attached to the outer ring 154. One of the fingers 157 protrudesradially inwardly in a first plane and the other finger 157 protrudesradially inwardly in a second plane spaced from and parallel to thefirst plane. The center hub 156 is positioned between the planes. Thefingers 157 are used to scrape proximal and distal regions of the mixingchamber 108 to ensure complete mixing. A protruding node 159 is alsoattached to the outer ring 154. The node 159 protrudes radiallyoutwardly to control spacing between the blade 152 and an innerperiphery of the cylinder wall 110 by scraping along the inner peripheryof the cylinder wall 110 in the mixing chamber 108.

FIGS. 8 and 8A illustrate alternative blades 252, 352 that could also beused to mix the bone cement. Each of the blades 152, 252, 352 isdesigned to flatten at the proximal end 104 of the cylinder 102 adjacentto the cap 112 after the blade 152, 252, 352 is released from the mixingshaft 150 in the mixing chamber 108. This ensures that the maximumpossible amount of bone cement can be discharged from the mixingcartridge 100. In the case of the preferred blade 152, the blade 152 isflexible and the outer wall 154 flattens into a plane perpendicular tothe longitudinal axis L and occupied by the center hub 156, asillustrated by hidden lines in FIG. 7A. Thus, the effective height H isreduced and the acute angle a becomes close to ninety degrees. This isaccomplished by twisting at the vanes 158. Spaces 155, 255, 355 formedin the center hub 156, 256, 356 ensure that once the blade 152, 252, 352is flattened, the bone cement can pass through the blade 152, 252, 352when discharged from the mixing cartridge 100. To further facilitate thedischarge of the bone cement past the blades 152, 252, 352, each of thecenter hubs 156, 256, 356 are sized to partially fit within the aperture130 defined in the cap 112.

Another alternative blade 452 is shown in FIG. 9. This blade 452 is arelatively thick disk 452 with chamfered ends 453 forming an acutechamfer angle with a sidewall 457. The chamfer angle is preferably sixtydegrees. In the preferred embodiment, the disk is about one half inchthick and about one eighth inch less in diameter than the innerperiphery of the cylinder wall 110. In one embodiment, the innerperiphery of the cylinder wall 110 is about two and one quarter inchesin diameter. As should be appreciated, the slight distance between theside wall 457 of the disk 452 and the inner periphery of the cylinderwall 110 creates a shear force on the bone cement as the disk 452 isrotated and moved axially in the mixing chamber 108. The shear force isthe force applied to the bone cement to mix the bone cement. This blade452 also includes a space 455 formed in a center of the disk 452 andears 460 for releasably attaching to the mixing shaft 150.

Referring to FIGS. 10-13 the mixing shaft 150 has a release latch 162for releasing the blade 152 from the mixing shaft 150 once mixing of thebone cement is complete. The release latch 162 moves between a holdingposition and a releasing position. In the holding position, the blade152 is secured to the mixing shaft 150 to mix the bone cement in themixing chamber 108. In the releasing position, the blade 152 is releasedfrom the mixing shaft 150 to remain in the mixing chamber 108 while themixing shaft 150 is removed from the cap 112 to make way for a nozzle204, as will be described further below. The release latch 162 isoperatively connected to a latch rod 164, which latches the blade 152 tothe mixing shaft 150 in the holding position. The latch rod 164 definesa split cavity 166 for receiving split legs 168 of the release latch 162in a snap-fit manner. The latch rod 164 is rotatably supported withinthe mixing shaft 150.

Referring to FIGS. 14A-14C, the transition of the release latch 162between the holding position and the releasing position is illustrated.Referring first to FIG. 14C, the exposed end 170 of the latch rod 164 isgenerally “T” shaped. The corresponding end 172 of the mixing shaft 150has opposed notches 174 that are adapted to receive the ears 160 on thecenter hub 156 of the blade 152. Initially, the ears 160 are positionedin the notches 174 and the exposed end 170 is positioned over the ears160 to hold the blade 152 to the mixing shaft 150. See FIG. 14A. Torelease the blade 152, the release latch 162 is depressed and rotated.Rotating the release latch 162 rotates the latch rod 164 with respect tothe mixing shaft 150 thus rotating the exposed end 170 away from theears 160 to release the blade 152. See FIG. 14B. With the blade 152released, the mixing shaft 150 is withdrawn from the cap 112 while theblade 152 remains in the mixing chamber 108.

A proximal end 176 of the mixing shaft 150, which represents a portionof the mixing shaft 150 extending outside of the mixing chamber 108during mixing, is adapted to engage a rotary power tool 177 (see FIG.37), such as a reamer drill, used to rotate the mixing shaft 150 andblade 152 and mix the bone cement. The proximal end 176 of the mixingshaft 150 is operatively connected to the blade 152 to transfer therotation of the rotary power tool 177 to the blade 152. When the blade152 is released from the mixing shaft 150, the operative connection isremoved. The operative connection is also removed if the portion of themixing shaft 150 extending outside of the mixing chamber 108 is severedfrom the rest of the mixing shaft 150 in the mixing chamber 108, as inalternative embodiments. A manually operated mixing handle (not shown)could engage the mixing shaft 150 at the proximal end 176 to mix thebone cement in other embodiments.

Referring to FIGS. 15-16, the piston 114 is positioned within the distalend 106 of the cylinder 102 to further seal the mixing chamber 108. Thepiston 114 has a skirt 178 extending about the inner periphery of thecylinder wall 110. The piston 114 also includes a proximal end 180 and adistal end 182 defining a cavity 184.

Referring specifically to FIG. 16, the piston 114 is releasably securedin a locked position in the distal end 106 of the cylinder 102 by alocking member 186. The locking member 186 is disposed in the cavity 184and includes diametrically opposed locking tabs 188 protruding intodiametrically opposed slots 190 defined in the cylinder wall 110 tosecure the piston 114 to the cylinder 102. It should be appreciated thatthe slots 190 could be in the form of any suitable female portion, e.g.,slot, groove, channel, etc., used for interlocking with a correspondingmale portion such as the locking tabs 188. Furthermore, while theembodiment of FIG. 16 illustrates two-way locking, i.e., the piston 114being locked from moving proximally and distally, the locking member 186could also be used for one-way locking, i.e., for preventing onlyproximal movement of the piston 114.

The locking member 186 is integrally formed from plastic and a resilientportion 192 of the locking member 186 biases the locking tabs 188radially outwardly from the longitudinal axis L into the slots 190. Theresilient portion 192 is in the form of a thin resilient ribbon 192acting like a spring and extending is a winding shape between thelocking tabs 188. The locking tabs 188 couple the locking member 186 tothe piston 114 by protruding through carrier slots 194 formed in theskirt 178. In the preferred embodiment, a step 196 protrudes into eachof the carrier slots 194 to define a guide for sliding engagement withina channel 198 partially defined in each of the locking tabs 188. In thelocked position, the carrier slots 194 are axially and radially alignedwith the slots 190 formed in the cylinder wall 110.

The piston 114 is locked at the distal end 106 of the cylinder 102 whilethe liquid and powder components are added and mixed in the mixingcartridge 100. The piston 114 is released from the locked position aftermixing of the bone cement is complete. Release buttons 200, integrallyformed with the locking tabs 188, are used to release the piston 114from the locked position. The release buttons 200 are disposed on thelocking tabs 188 and protrude distally therefrom. Each of the releasebuttons 200 includes a cam surface 202 forming an acute angle with thelongitudinal axis L. The piston 114 is released from the locked positionby squeezing the release buttons 200 radially inwardly against the biasof the resilient portion 192 to withdraw the locking tabs 188 from theslots 190. This action can be performed either manually or mechanically,as will be described further below. After release from the slots 190,the locking tabs 188 remain coupled to the piston 114 in the carrierslots 194.

Referring to FIGS. 17-18, an alternative locking member 386 is shown.The alternative locking member 386 includes locking tabs 388 that arebiased radially outwardly from the longitudinal axis L of the cylinder302 to engage the slots 390 in the cylinder wall 310. In thisembodiment, four slots 390 are defined in the cylinder wall 310 toreceive the locking tabs 388. The resilient portion 392 is furtherdefined as a resilient base 392 resiliently supporting each of thelocking tabs 388 on the piston 314 with each of the locking tabs 388being radially biased outwardly from the skirt 378 of the piston 314 toengage the slots 390 in the cylinder wall 310. The release buttons 400are further defined as fingers 400 extending radially inwardly towardthe longitudinal axis L of the cylinder 302 with the fingers 400 beingengageable to urge the locking tabs 388 radially inwardly and withdrawthe locking tabs 388 from the slots 390 in the cylinder wall 310 torelease the piston 314 from the locked position.

Referring to FIGS. 19-23, once the bone cement is mixed, and the mixingshaft 150 is withdrawn from the cap 112, the nozzle 204 is positioned onthe cap 112. In the disclosed embodiment, the nozzle 204 is set in placeby pushing a hollow shaft 205 of the nozzle 204 down into the orifice130 of the cap 112 and then twisting the nozzle 204 slightly, aboutone-quarter turn. The nozzle 204 is attached to the cap 112 to preparethe mixing cartridge 100 for placement into the delivery gun 500.

The cap 112 has a nipple 206 protruding from an outer surface 208thereof. The nipple 206 has tabs 210, which engage detent members 212 inthe nozzle 204. After the nozzle 204 is fully rotated into position, thetabs 210 fully engage the detent members 212 while being positionedproximal to the detent members 212 to secure the nozzle 204 in place. Astop 214 on the cap 112, best shown in FIG. 19, prevents the nozzle 204from rotating freely in the clockwise direction after the tabs 210 haveengaged the detent members 212. The stop 214 extends downwardly from oneof the tabs 210 to abut a side surface 216 of one of the detent members212 to prevent further clockwise rotation.

The nozzle 204 and cap 112 have first 218 and second 220 lockingprotrusions. The first locking protrusion 218 acts as a detent andslides over the second locking protrusion 220 to a locked position asillustrated in FIG. 21. In this position, rear flat surfaces 222, 224 ofthe locking protrusions 218, 220, abut one another to prevent the nozzle204 from being turned in the opposite direction, thereby preventingremoval of the nozzle 204 from the cap 112. The nozzle 204 can beremoved by deflecting an outer skirt 226 of the nozzle 204 and rotatingthe nozzle 204 counterclockwise thereby disengaging the lockingprotrusions 218, 220. Both the nozzle 204 and cap 112 are formed fromplastic, which facilitates the detent-like locking and unlocking of thenozzle 204 to the cap 112.

With the nozzle 204 in place, the mixing cartridge 100 is ready to beplaced within the delivery gun 500. Referring to FIG. 24, the deliverygun 500 of the present invention includes a cradle 502 for supportingthe mixing cartridge 100 and a casing 504 fixed to the cradle 502 forsupporting a drive mechanism 506, a linkage system 508, andcorresponding components. The cradle 502 includes an endplate 510, whichhas an opening 512 for receipt of the nozzle 204. The endplate 510 holdsthe mixing cartridge 100 in position in the cradle 502. In the preferredembodiment, the casing 504 and the endplate 510 are connected by twoconnecting bars 514 (one on each side of the mixing cartridge 100) toreduce the weight of the delivery gun 500. A handle 516 is integrallyformed with the casing 504 to maneuver the delivery gun 500 during use.

To dispense the bone cement from the mixing cartridge 100, the piston114 must first be released from the locked position. Referring to FIG.25, this is accomplished using a release mechanism 518 integrated intothe delivery gun 500. Once the mixing cartridge 100 is in place in thecradle 502, a ram disk 520 protrudes into the cavity 184 in the distalend 182 of the piston 114. The release mechanism 518 is integrated intothe ram disk 520. The release mechanism 518 includes a bearing surface522 forming an acute angle with the longitudinal axis L for catching therelease buttons 200 to cam the release buttons 200 radially inwardly.More specifically, the cam surfaces 202 of the release buttons 200 slidealong the bearing surface 522, while being cammed radially inwardly.This action pulls the locking tabs 188 radially inwardly to withdraw thelocking tabs 188 from the slots 190 in the cylinder wall 110 and releasethe piston 114 from the locked position (when the alternative piston 314is used, the ram disk has a flat bearing surface that axially pressesthe fingers 400 proximally to bend each resilient base 392 inwardly andurge the locking tabs 388 radially inward). A centering pin 800 can beused to center the ram disk 520 in a centering cavity 802 of the piston114 to facilitate the release of the piston 114 from the lockedposition.

Referring back to FIG. 24, once the piston 114 is released, the piston114 can be driven through the mixing chamber 108 by the drive mechanism506 to force the bone cement from the nozzle 204. The drive mechanism506 includes a drive rod 524 movably supported by bushings 526 in thecasing 504. The ram disk 520 is fixed to the drive rod 524. The drivemechanism 506 further includes a first gripper plate 528 responsive tomovement of the linkage system 508 upon actuation of a trigger 530. Thefirst gripper plate 528 defines an aperture surrounding the drive rod524. The first gripper plate 528 frictionally engages the drive rod 524to advance the drive rod 524. The first gripper plate 528 is urgedforward while in frictional contact with the drive rod 524 by thelinkage system 508 when the trigger 530 is actuated. The first gripperplate 528 thereby advances the drive rod 524 and ram disk 520 relativeto the casing 504 to drive the piston 114 and force the bone cement fromthe mixing cartridge 100. The trigger 530 is pivotally supported by thecasing 504 and operatively connected to the drive mechanism 506 toadvance the drive mechanism 506 upon actuation of the trigger 530.

The linkage system 508 includes a first link 532, which is pivotallymounted to the casing 504 about a pivot axis A adjacent to the firstgripper plate 528. The first link 532 is adapted to engage the firstgripper plate 528 when the first link 532 pivots about the pivot axis A.A second link 536 pivotally interconnects the trigger 530 to the firstlink 532 via support pins 538, 540. The links 532, 536 and trigger 530are interconnected to move in unison upon rotation of the trigger 530about a second pivot axis B. When the trigger 530 is pulled, the secondlink 536 rotates the first link 532 about the pivot axis A, whichengages the first gripper plate 528 and urges the first gripper plate528 forward while the first gripper plate 528 is in frictionalengagement with the drive rod 524 thereby advancing the drive rod 524. Areturn spring 542 returns the links 532, 536 and the trigger 530 to aninitial position upon release of the trigger 530. At the same time, afirst spring 534 momentarily disengages the first gripper plate 528 fromthe drive rod 524 to slide the first gripper plate 528 back to aninitial position to await the next pull of the trigger 530. The casing504 pivotally supports the first link 532 and the trigger 530 about thepivot axes A and B via support pins 544, 546.

A speed-changing link 548 is pivotally connected to the second link 536about a support pin 549. The speed-changing link 548 selectively pivotsinto and out from engagement with the first gripper plate 528 by way ofa switch 550. The speed-changing link 548 pivots between a high-speedposition and a low-speed position about the support pin 549 (thelow-speed position is shown in FIG. 24). The high-speed positioncorresponds to faster advancement of the drive rod 524 at a lower force.This allows the user to quickly advance the drive rod 524 to drive thepiston 114 and dispense high volumes of bone cement at low pressure. Thelow-speed position corresponds to slower advancement of the drive rod524 at a higher force, which exerts more force on the piston 114 topressurize the bone cement.

The first gripper plate 528 and the speed-changing link 548 havecomplementary first and second coupling devices 552, 554 used to couplethe first gripper plate 528 with the speed-changing link 548 in thehigh-speed position. More specifically, in the embodiment of FIG. 24,the first gripper plate 528 has a shoulder 552 that is received within achannel 554 on the speed-changing link 548. The speed-changing link 548engages the shoulder 552 in the high-speed position. In the high-speedposition, a user's gripping force is transmitted through the trigger 530to the second link 536 and the speed-changing link 548 to engage thefirst gripper plate 528 and advance the drive rod 524. Thespeed-changing link 548 is isolated from the first gripper plate 528 inthe low-speed position. The low-speed position corresponds to thespeed-changing link 548 being switched or disconnected from the shoulder552. In the low-speed position, the user's gripping force is transmittedthrough the trigger 530 to both the first 532 and second 536 links toengage the first gripper plate 528 and advance the drive rod 524. Thisresults in slower advancement of the drive rod 524, but at a much highermechanical advantage than the high-speed position. As a result, the usercan better pressurize the bone cement during injection.

The pivot axes A and B and the links 532, 536, 548 are positioned abovethe drive rod 524, while the trigger 530 extends below the drive rod524. A channel 556 defined in the trigger 530 facilitates thisconfiguration. There are several advantages to this configuration.Moving the second pivot axis B away from a user's hand results in betterusage of the stronger index and ring fingers by allowing those fingersmore travel distance as the trigger 530 is actuated. This configurationalso allows the handle 516 to be closer to the drive rod 524, which isbelieved to reduce wrist strain when the user pushes the delivery gun500 forward during cement pressurization. Another benefit is that itallows for a more streamlined casing design and better weightdistribution.

In one embodiment, shown in FIG. 24, a secondary gripper plate 562 ismounted about the drive rod 524 adjacent to the first gripper plate 528.The addition of one or more secondary gripper plates 562 to the firstgripper plate 528 adds strength to the delivery gun 500 while stillpermitting proper operation. By using two or more gripper plates 528,562, increased frictional contact with the drive rod 524 is obtainedwithout adversely affecting performance.

A release pin 558 disengages the gripper plates 528, 562 to allow a userto freely move the drive rod 524 by hand. The release pin 558 isconnected to a retainer plate 560 and is adapted to engage the firstgripper plate 528. When the retainer plate 560 is pushed by the user,the release pin 558 engages the first gripper plate 528 which forces thefirst gripper plate 528 to tilt back against the bias of the firstspring 534 thus releasing the drive rod 524. Any secondary gripperplates 562 follow. As should be appreciated, pushing the retainer plate560 also pivots the retainer plate 560 releasing its engagement with thedrive rod 524. With both the retainer plate 560 and the gripper plates528, 562 released, the drive rod 524 is free to move. This allows theuser to manually move the drive rod 524 with respect to the casing 504.

The delivery gun 500 is unique among bone cement guns with afriction-plate mechanism in the way that it handles wear and deformationof the gripper plates 528, 562. In the disclosed embodiments, thegripper plates 528, 562 are tilted by the first spring 534 intofrictional contact with the drive rod 524. Regardless of the amount ofwear or deformation of the gripper plates 528, 562 or the drive rod 524,the gripper plates 528, 562 require no further tilting to engage thedrive rod 524 upon actuation of the trigger 530. Thus, advancement ofthe drive rod 524 is produced over the entire actuation of the trigger530 and efficiency is maintained throughout the life of the delivery gun500.

Referring to FIGS. 24A and 24B, alternatives of the linkage system 508′and 508″ are shown. These alternatives are represented with similarnumerals to the embodiment of FIG. 24 to indicate like parts. FIG. 24Aillustrates a configuration of the linkage system 508′ in which thelinkage system 508′ lies beneath the drive rod 524′. Furthermore, thespeed-changing link 548′ in this embodiment is pivotally connected tothe first gripper plate 528′ and includes a hook-shaped end to engagethe support pin 538′ in the high-speed position and disengage thesupport pin 538′ in the low-speed position. FIG. 24B illustrates aconfiguration of the linkage system 508″ in which the first gripperplate 528″ is pushed by the linkage system 508″, as opposed to beingpulled by the linkage system 508 and 508′ in FIGS. 24 and 24A. Here, thespeed-changing link 548″ is pivotally connected to the first gripperplate 528″ to pivot into engagement with a notch 555″ defined in thetrigger 530″ in the high-speed position and out from engagement with thenotch 555″ in the low-speed position. These alternatives of the linkagesystem 508′ and 508″ illustrate the flexibility of design, e.g., theselection of mechanical advantage, provided by the linkage system of thepresent invention.

Referring to FIGS. 26-27, an alternative embodiment of the drivemechanism 606 and linkage system 608 is shown (only a portion of thedrive mechanism 606 and linkage system 608 is shown for illustrativepurposes). In this embodiment, the linkage system 608 comprises the samecomponents as previously described with an improved first link 632 andgripper plates 628, 662. In this embodiment, a plurality of secondarygripper plates 662 are aligned along the drive rod 624 next to the firstgripper plate 628. The first link 632 defines a female recess 664 andthe first gripper plate 628 includes a male member 668 for matingengagement with the female recess 664. The secondary gripper plates 662are aligned relative to the first gripper plate 628 via mating notches670 and pegs 672 formed therein. The notches 670 and pegs 672 assume thesame shape to mate with one another and maintain alignment. Thisarrangement minimizes alignment changes that may cause slipping oruneven wear. The arrangement also reduces contact between the gripperplates 628, 662 and an interior wall of the casing 504. The gripperplates 628, 662 are shown spaced in FIG. 26 for illustration only. Inpractice, the gripper plates 628, 662 abut one another, as shown in FIG.27.

In this embodiment, each of the gripper plates 628, 662 also defines apair of semi-spherical grooves 674. In FIG. 26, only the first of thepair of grooves 674 are shown in each of the gripper plates 628, 662.The other of the pair of grooves 674 is located in a rear surface ofeach of the gripper plates 628, 662, cater-cornered from the first ofthe pair of grooves 674. These grooves 674 increase the frictionalcontact with the drive rod 624. When the gripper plates 628, 662 areurged forward while in frictional engagement with the drive rod 624 bythe first link 632, a substantial portion of a rim 676 defined by eachof the grooves 674 frictionally contacts the drive rod 624.

Referring to FIG. 27, autoclave sterilization of the delivery gun 500can create a tendency for the gripper plates 628, 662 to adhere to thedrive rod 624 beyond their initial positions when the trigger 630 isreleased. In this situation the first spring 634 cannot produce enoughforce to disengage the gripper plates 628, 662 from the drive rod 624,and the gripper plates 628, 662 do not return to their initialpositions. FIG. 27 shows a way to prevent this condition. A striker 678,in the form of a downwardly protruding portion of the second link 636,closely follows one of the gripper plates 628, 662 during actuation ofthe trigger 630. In the event that any of the gripper plates 628, 662 donot properly disengage the drive rod 624 upon release of the trigger630, the striker 678 will contact the notch 670 in the closest gripperplate 628, 662 and dislodge the gripper plate 628, 662 from the driverod 624. The first spring 634 can then properly return the gripperplates 628, 662 to their initial positions.

A coating has been added to an exterior of each of the gripper plates528, 562, 628, 662 in FIGS. 24 and 26-27. The coating increaseslubricity and corrosion resistance. This facilitates sliding between thegripper plates 528, 562, 628, 662 as they engage the drive rod 524, 624.The coating also reduces corrosion due to autoclave sterilization thatmay cause the gripper plates 528, 562, 628, 662 to adhere to one anotherand prevent proper engagement with the drive rod 524, 624. The coatingused may be Electroless-Nickel with polytetrafluoroethylene (PTFE) orother like coatings possessing the same or similar properties.

Referring to FIGS. 28-31, another alternative embodiment of the drivemechanism 706 and linkage system 708 is shown. This embodiment alsoprovides selective high-speed and low-speed advancement of the drive rod724. This alternative drive mechanism 706 eliminates the gripper plateby providing teeth 780 on the drive rod 724. A cross-section of thedrive rod 724 shows the teeth 780 on a flat upper surface 782, while alower surface 784 is smooth and round. The first link 732, which inprevious embodiments urged’ the first gripper plate 528, 628 forwardwith the drive rod 524, 624, now pivotally supports a first pawl member786. The first pawl member 786 is spring-biased into engagement with theteeth 780.

A second pawl member 788 is pivotally supported by the second link 736.The second pawl member 788 is pivotable between a high-speed position inwhich the second pawl member 788 is spring-biased into engagement withthe teeth 780 to advance the drive rod 724, and a low-speed position inwhich the second pawl member 788 is disengaged and isolated from theteeth 780. In the low-speed position, the first pawl member 786 advancesthe drive rod 724. The low-speed position is illustrated in FIGS. 28-29.In the high-speed position, with the second pawl member 788 engaging theteeth 780, the first pawl member 786 remains in engagement with theteeth 780, but only ratchets along the teeth 780 as the second pawlmember 788 advances the drive rod 724. The high-speed position isillustrated in FIGS. 30-31. The principle of increasing mechanicaladvantage in the low-speed position relative to the high-speed positionalso applies in this embodiment.

The switch 750 is used to pivot the second pawl member 788 out fromengagement with the teeth 780 of the drive rod 724 in the low-speedposition (see FIGS. 28-29) and into engagement with the teeth 780 in thehigh-speed position (see FIGS. 30-31). A switch similar to that shown inU.S. Pat. No. 5,431,654 to Nic, herein incorporated by reference, can beused for this purpose. The switch 750 extends through the casing 704 andterminates in a button that is manipulated by a user to move the secondpawl member 788 between the high-speed and low-speed positions (seebriefly FIGS. 41-42). This also applies to the switch 550 used to movethe speed-changing link 548 in previous embodiments.

In this embodiment, the retainer plate 560 can be removed. In its place,a spring-biased non-return pawl member 790 retains the drive rod 724 inposition upon advancement. The drive rod 724 can be freely moved in thecasing 704 by rotating the drive rod 724 one hundred and eighty degreessuch that the pawl members 786, 788, 790 are out of engagement with theteeth 780. Upon such rotation, the pawl members 786, 788, 790 ride onthe smooth lower surface 784 of the drive rod 724 allowing the user tofreely pull the drive rod 724 relative to the casing 704. This isgenerally disclosed in the '654 patent to Nic.

Each of the pawl members 786, 788, 790 are pivotally supported by pins.Springs, such as those shown in the '654 patent to Nic, bias the pawlmembers into engagement with the teeth 780 on the drive rod 724 (exceptwhen the switch 750 acts against the bias of the spring in the low-speedposition to disengage the second pawl member 788 from the teeth 780).

Mixing and delivery of the bone cement will now be described withreference to FIGS. 32-42. Referring first to FIG. 32, a bone cementloading system is shown. The bone cement loading system comprises a base900 supporting the cylinder 102 while loading the liquid and powdercomponents of the bone cement into the mixing chamber 108. The baseincludes a cavity for receiving the distal end 106 of the cylinder 102.Detents 903 are formed in the cavity. A groove 905 is defined in anouter surface of the cylinder 102 to receive the detents 903 andfacilitate a snug fit between the base 900 and the cylinder 102. Itshould be appreciated that the detents 903 could be formed on thecylinder 102 with the groove 905 defined in the base 900. The distal end106 of the cylinder 102 may also be press fit into the base 900. Thebase 900 is oblong and oval in shape to fully support the cylinder 102on a work surface, while the cavity is circular in shape to fit thecircular shaped cylinder 102. A funnel 902 couples to the cylinder 102to channel the powder into the cylinder 102 during loading. The funnel902 includes a proximal end 911 having an oblong oval-shaped peripheryto facilitate the loading of the powder into the mixing chamber 108 anda distal end 909 having a circular periphery to snugly fit inside theproximal end 104 of the cylinder 102.

FIGS. 33-42 illustrate ten steps for preparing and injecting the bonecement. The mixing cartridge 100, delivery gun 500, and other componentsare generically shown in each step for illustrative purposes only.

In STEP 1, shown in FIG. 33, the funnel 902 is coupled to the cylinder102 and the powder is poured into the mixing chamber 108.

In STEP 2, shown in FIG. 34, after the powder is poured into the mixingchamber 108, the funnel 902 is removed, and the liquid component, e.g.,liquid monomer, of the bone cement is added. In this manner, the presentinvention avoids wetting of the funnel 902 and the associated clean-up.

In STEP 3, shown in FIG. 35, the cap 112 with the mixing shaft 150 andblade 152 supported therein is attached to the cylinder 102.

In STEP 4, shown in FIG. 36, the vacuum line 138 is attached to thevacuum port 136 and a vacuum is drawn in the mixing chamber 108 with theliquid and powder components therein.

In STEP 5, shown in FIG. 37, with the vacuum drawn, the power tool(reamer) is then connected to the mixing shaft 150.

In STEP 6, shown in FIG. 38, with the vacuum still drawn, the mixingshaft 150 is moved axially with respect to the mixing cartridge 100 androtated by the power tool. The blade 152 (not shown in FIG. 38) is movedaxially the entire extent of the mixing cartridge 100 while rotating toensure that the liquid and powder components are fully mixed.

In STEP 7, shown in FIG. 39, once mixed, the release latch 162 is movedto release the blade 152 (not shown in FIG. 39). The blade 152 remainsin the mixing chamber 108 once released. The mixing shaft 150 is thenremoved from the mixing cartridge 100. Mixing is now complete.

In STEP 8, shown in FIG. 40, the nozzle 204 is pushed down on the cap112 and rotated into place.

In STEP 9, shown in FIG. 41, the mixing cartridge 100 is positioned inthe cradle 502.

In STEP, shown in FIG. 42, the piston 114 is released from the distalend 106 of the cylinder 102 and the delivery gun 500 is primed and readyto discharge the bone cement from the mixing cartridge 100.

It will be appreciated that the above description relates to thedisclosed embodiments by way of example only. Many apparent variationsof the disclosed invention will be known to those of skill in this areaand are considered to be within the scope of this invention and areconsidered to be within the scope of the following claims. Obviously,many modifications and variations of the present invention are possiblein light of the above teachings.

1-72. (canceled)
 73. A cartridge for dispensing bone cement, saidcartridge including: a cylinder having first and second opposed endswith a void space between the ends in which bone cement is disposed, thecylinder first end being open, the cylinder second end being closedwherein an outer surface extends over the cylinder second end; a bossthat extends outwardly from cylinder second so as to extend away fromthe outer surface over the cylinder second end, wherein said boss isformed to have an opening that extends through said boss and thecylinder second end surface into the cylinder void space, the openingbeing the opening through which cement is discharged from said cylinder;a plurality of primary tabs that extend radially outwardly from saidboss, said tabs being arcuately spaced apart from each other and beingspaced away from the cap outer surface; and at least one secondary tab,said secondary tab being integral with and extending downwardly from oneof said primary tabs; a piston, said piston being disposed in thecylinder void space adjacent the first end of said cylinder, said pistonbeing slidably mounted in the cylinder void space so as to move towardsthe first end of said cylinder so as to push bone cement out through theboss opening; and a nozzle, said nozzle having: a tubular base, saidbase being dimensioned to seat in the boss opening and having a open endlocated adjacent the second end of said cylinder, wherein when said baseis seated in the boss opening, said nozzle including said base, is ableto rotate around an axis that extends through the opening; a skirt thatis mounted to said base so as to extend circumferentially around saidbase and so as to be spaced radially outwardly of said base, whereinsaid skirt is further dimensioned so that when said nozzle base isseated in the boss opening, said skirt extends over said primary tabs ofsaid boss; and a plurality of ribs, said primary ribs extending inwardlyfrom an inner surface of said skirt towards said base, said ribsarcuately spaced apart from each other so that, when said nozzle base isseated in said base opening, said ribs are located between said primarytabs and said ribs being further positioned so that upon the rotation ofsaid nozzle base, each said rib moves into registration below one ofsaid boss primary ribs and so that the further rotation of said nozzleis inhibited by the abutment of one of said ribs against said at leastone secondary tab.
 74. The cartridge of claim 73, wherein: a cap isremovably attached to said cylinder over the second end of saidcylinder, said cap forming the outer surface that extends of the secondend of said cylinder; and said boss is integral with and extends awayfrom said cap.
 75. The cartridge of claim 73, wherein said cap and saidskirt further including interlocking features that, upon rotation ofsaid nozzle to position said nozzle ribs in registration with said bosstabs, releasably inhibit counter rotation of said nozzle.
 76. Thecartridge of claim 75, wherein: said cap is formed with a raised memberthat extends above the outer surface that functions as said capinterlocking feature; said skirt has a finger that extends outwardlyfrom said skirt that functions as said nozzle interlocking featurewherein said cap raised member and said skirt finger are collectivelypositioned so that, upon the rotation of said nozzle to position saidnozzle ribs in registration with said boss tabs, said finger abuts saidraised member so as to inhibit rotation counter rotation of said nozzle;and said skirt is formed from deflectable material so that said skirtfinger can be moved away from said cap raised member to allow counterrotation of said nozzle.
 77. The cartridge of claim 73, wherein saidnozzle is further formed so that: said skirt has an open end, the openend of said skirt being the portion of said skirt that is disposedagainst the outer surface of said cap; and the open end of said nozzlebase is located outwardly from the open end of said skirt.
 78. Thecartridge of claim 73, wherein said piston is releasably locked to saidcylinder.
 79. The cartridge of claim 73, wherein said skirt is formedwith a plurality of windows and each said rib is located below one ofsaid windows.
 80. The cartridge of claim 73, further including: a bladedisposed in the cylinder void space; and a shaft that is connected tosaid blade and that extends out of said cylinder, said shaft moveable soto be able to both rotate said blade within the cylinder void space andmove said blade longitudinally through the void space.
 81. A cartridgefor dispensing bone cement, said cartridge including: a cylinder havingfirst and second opposed ends with a void space between the ends inwhich bone cement is disposed, the cylinder first end being open; a cap,said cap having: an outer surface that extends over the second end ofsaid cylinder; a boss that extends outwardly from the outer surface ofsaid cap, said boss being formed to have an opening that extends throughsaid boss into the cylinder void space, the opening being the openingthrough which cement is discharged from said cylinder; a plurality ofprimary tabs that extend radially outwardly from said boss, said tabsbeing arcuately spaced apart from each other and being spaced away fromthe cap outer surface; at least one secondary tab, said secondary tabbeing integral with and extending downwardly from one of said bossprimary tabs; a nozzle, said nozzle having: a tubular base, said basebeing dimensioned to seat in the boss opening and having a open endlocated adjacent the second end of said cylinder, wherein when said baseis seated in the boss opening, said nozzle including said base, is ableto rotate around an axis that extends through the opening; a skirt thatis mounted to said base so as to extend circumferentially around saidbase and so as to be spaced radially outwardly of said base, whereinsaid skirt is further dimensioned so that when said nozzle base isseated in the boss opening, said skirt extends over said primary tabs ofsaid boss; and a plurality of ribs, said primary ribs extending inwardlyfrom an inner surface of said skirt towards said base, said ribsarcuately spaced apart from each other so that, when said nozzle base isseated in said base opening, said ribs are located between said primarytabs and said ribs being further positioned so that upon the rotation ofsaid nozzle base, each said rib moves into registration between said capouter surface and one of said boss primary ribs and so that the furtherrotation of said nozzle is inhibited by the abutment of one of said ribsagainst said at least one secondary tab; complementary interlockingfeatures formed on said cap outer surface and said nozzle skirt, saidinterlocking features positioned and shaped so that, when said nozzle isrotated to place said skit ribs in registration with said boss tabs,said interlocking features abut to releasably prevent counter rotationof said nozzle; and a piston, said piston being disposed in the cylindervoid space adjacent the first end of said cylinder, said piston beingslidably mounted in the cylinder void space so as to move towards thefirst end of said cylinder so as to push bone cement out through theboss opening and into said nozzle.
 82. The cartridge of claim 81,wherein said cap is removably attached to said cylinder.
 83. Thecartridge of claim 81, wherein: said cap is formed with a raised memberthat extends above the outer surface that functions as said capinterlocking feature; said skirt has a finger that extends outwardlyfrom said skirt that functions as said nozzle interlocking featurewherein said cap raised member and said skirt finger are collectivelypositioned so that, upon the rotation of said nozzle to position saidnozzle ribs in registration with said boss tabs, said finger abuts saidraised member so as to inhibit rotation counter rotation of said nozzle;and said skirt is formed from deflectable material so that said skirtfinger can be moved away from said cap raised member to allow counterrotation of said nozzle.
 84. The cartridge of claim 81, wherein saidnozzle is further formed so that: said skirt has an open end, the openend of said skirt being the portion of said skirt that is disposedagainst the outer surface of said cap; and the open end of said nozzlebase is located outwardly from the open end of said nozzle skirt. 85.The cartridge of claim 81, wherein said piston is releasably locked tosaid cylinder.
 86. The cartridge of claim 81, wherein said nozzle has astem that extends away from said cylinder and said nozzle skirt, saidstem being formed with an open end through which cement is dischargedfrom said cartridge.
 87. A cartridge for dispensing bone cement, saidcartridge including: a cylinder having first and second opposed endswith a void space between the ends in which bone cement is disposed, thecylinder first end being open; a cap, said cap having: an outer surfacethat extends over the second end of said cylinder; a boss that extendsoutwardly from the outer surface of said cap, said boss being formed tohave an opening that extends through said boss into the cylinder voidspace, the opening being the opening through which cement is dischargedfrom said cylinder; a plurality of primary tabs that extend radiallyoutwardly from said boss, said tabs being arcuately spaced apart fromeach other and being spaced away from the cap outer surface; at leastone secondary tab, said secondary tab being integral with and extendingdownwardly from one of said boss primary tabs; a blade disposed in thecylinder void space; a shaft, said shaft having a first end that isattached to said blade, said shaft extends through the boss opening soas to extend out of said cylinder and wherein: said shaft is moveablerelative to said cylinder so that movement of said shaft results in themovement of said blade within the cylinder void space; and said shaftcan be detached from said blade so that said shaft can be removed fromthe boss opening; a nozzle, said nozzle having: a tubular base, saidbase being dimensioned to seat in the boss opening upon the removal ofsaid shaft from the opening and having a open end located adjacent thesecond end of said cylinder, wherein when said base is seated in theboss opening, said nozzle including said base, is able to rotate aroundan axis that extends through the opening; a skirt that is mounted tosaid base so as to extend circumferentially around said base and so asto be spaced radially outwardly of said base, wherein said skirt isfurther dimensioned so that when said nozzle base is seated in the bossopening, said skirt extends over said primary tabs of said boss; and aplurality of ribs, said primary ribs extending inwardly from an innersurface of said skirt towards said base, said ribs arcuately spacedapart from each other so that, when said nozzle base is seated in saidbase opening, said ribs are located between said primary tabs and saidribs being further positioned so that upon the rotation of said nozzlebase, each said rib moves into registration between said cap outersurface and one of said boss primary ribs and so that the furtherrotation of said nozzle is inhibited by the abutment of one of said ribsagainst said at least one secondary tab; complementary interlockingfeatures formed on said cap outer surface and said nozzle skirt, saidinterlocking features positioned and shaped so that, when said nozzle isrotated to place said skit ribs in registration with said boss tabs,said interlocking features abut to releasably prevent counter rotationof said nozzle; and a piston, said piston being disposed in the cylindervoid space adjacent the first end of said cylinder, said piston beingslidably mounted in the cylinder void space so as to move towards thefirst end of said cylinder so as to push bone cement out through theboss opening and into said nozzle.
 88. The cartridge of claim 87,wherein said cap is removably attached to said cylinder.
 89. Thecartridge of claim 87, wherein said cap and said skirt further includinginterlocking features that, upon rotation of said nozzle to positionsaid nozzle ribs in registration with said boss tabs, releasably inhibitcounter rotation of said nozzle.
 90. The cartridge of claim 89, wherein:said cap is formed with a raised member that extends above the outersurface that functions as said cap interlocking feature; said skirt hasa finger that extends outwardly from said skirt that functions as saidnozzle interlocking feature wherein said cap raised member and saidskirt finger are collectively positioned so that, upon the rotation ofsaid nozzle to position said nozzle ribs in registration with said bosstabs, said finger abuts said raised member so as to inhibit rotationcounter rotation of said nozzle; and said skirt is formed fromdeflectable material so that said skirt finger can be moved away fromsaid cap raised member to allow counter rotation of said nozzle.
 91. Thecartridge of claim 87, wherein said shaft includes a latch mechanismthat releasably holds said blade to said shaft and latch mechanisminclude a manually actuated release button that is moveably mounted to aportion of said shaft this is located outside of said cartridge.
 92. Thecartridge of claim 87, wherein said nozzle is further formed so that:said skirt has an open end, the open end of said skirt being the portionof said skirt that is disposed against the outer surface of said cap;and the open end of said nozzle base is located outwardly from the openend of said nozzle skirt.
 93. The cartridge of claim 87, wherein saidpiston is releasably locked to said cylinder.